1 CMS WILL NO LONGER BE PROVIDING PAPER COPIES OF HANDOUTS FOR THE MEETING. ELECTRONIC COPIES OF ALL MEETING MATERIALS WILL BE POSTED ON THE CMS WEBSITE PRIOR TO THE MEETING AT HTTPS://WWW.CMS.HHS.GOV/ICD9PROVIDERDIAGNOSTICCODES/03_MEETINGS.ASP DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, Maryland 21244-1850 Agenda ICD-9-CM Coordination and Maintenance Committee Department of Health and Human Services Centers for Medicare & Medicaid Services CMS Auditorium 7500 Security Boulevard Baltimore, MD 21244-1850 ICD-9-CM and ICD-10-CM/PCS March 5, 2013 Pat Brooks, CMS – Co-Chairperson 9:00 AM – 12:30 PM ICD-10-PCS and ICD-9-CM Procedure presentations with public comment 12:30 PM – 1:30 PM Lunch break 1:30 PM – 5:00 PM Diagnosis presentations with public comment Note: Proposals for the diagnosis codes will begin following the conclusion of the procedure presentations and will be led by the Centers for Disease Control (CDC). Please visit CDCs website for the Diagnosis agenda located at the following address: http://www.cdc.gov/nchs/icd/icd9cm_maintenance.htm This meeting is being webcast via CMS at http://www.cms.gov/live/. By your attendance, you are giving consent to the use and distribution of your name, likeness and voice during the meeting. You are also giving consent to the use and distribution of any personally identifiable information that you or others may disclose about you during the meeting. Please do not disclose personal health information. If participating via the webcast you do NOT need to register for the meeting. Conference lines will also be available for those participants who are unable to view the webcast or attend in person. Toll free dial in access for external participants is as follows: Phone: 1-877-267-1577 Meeting ID: 6601 If dialing in you do NOT need to register on-line for the meeting.
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1
CMS WILL NO LONGER BE PROVIDING PAPER COPIES OF HANDOUTS FOR THE MEETING. ELECTRONIC COPIES OF ALL MEETING MATERIALS WILL BE POSTED ON THE CMS WEBSITE PRIOR TO THE MEETING AT HTTPS://WWW.CMS.HHS.GOV/ICD9PROVIDERDIAGNOSTICCODES/03_MEETINGS.ASP
DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850
Agenda
ICD-9-CM Coordination and Maintenance Committee
Department of Health and Human Services
Centers for Medicare & Medicaid Services
CMS Auditorium
7500 Security Boulevard
Baltimore, MD 21244-1850
ICD-9-CM and ICD-10-CM/PCS
March 5, 2013
Pat Brooks, CMS – Co-Chairperson
9:00 AM – 12:30 PM ICD-10-PCS and ICD-9-CM Procedure presentations with public
comment
12:30 PM – 1:30 PM Lunch break
1:30 PM – 5:00 PM Diagnosis presentations with public comment
Note: Proposals for the diagnosis codes will begin following the conclusion of the
procedure presentations and will be led by the Centers for Disease Control (CDC). Please
visit CDCs website for the Diagnosis agenda located at the following address:
Continuing education credits may be awarded by the American Academy of Professional Coders
(AAPC) or the American Health Information Management Association (AHIMA) for
participation in CMS ICD-9-CM Coordination and Maintenance (C&M) Committee Meeting
Conference Calls, Webcasts or on-site Meetings.
Continuing Education Information for American Academy of Professional Coders (AAPC) If you have attended or are planning to attend a CMS ICD-9-CM Coordination and Maintenance
(C&M) Committee Meeting Conference Call, Webcast or on-site Meeting, you should be aware
that CMS does not provide certificates of attendance for these. Instead, the AAPC will accept
your e-mailed confirmation and call or meeting description as proof of participation. Please
retain a copy of your e-mailed confirmation for these as the AAPC will request them for any
conference call or meeting you entered into your CEU Tracker if you are chosen for CEU
verification. Members are awarded one (1) CEU per hour of participation.
Continuing Education Information for American Health Information Management
Association (AHIMA) AHIMA credential-holders may claim 1 CEU per 60 minutes of attendance at an educational
program. Maintain documentation about the program for verification purposes in the event of an
audit. A program does not need to be pre-approved by AHIMA, nor does a CEU certificate need
to be provided, in order to claim AHIMA CEU credit. For detailed information about AHIMA's
CEU requirements, see the Recertification Guide on AHIMA's web site.
Please note: The statements above are standard language provided to CMS by the AAPC
and the AHIMA. If you have any questions concerning either statement, please contact the
respective organization, not CMS.
5
ICD-9-CM TIMELINE A timeline of important dates in the ICD-9-CM process is described below:
March 5, 2013 ICD-9-CM Coordination and Maintenance Committee
meeting.
April 1, 2013 There were no requests for ICD-9-CM codes to capture new
technology for implementation on April 1, 2013. Therefore, there
will be no new ICD-9-CM procedure codes implemented on April
1, 2013.
April 6, 2013 Deadline for receipt of public comments on proposed code
revisions discussed at the March 5, 2013 ICD-9-CM
Coordination and Maintenance Committee meetings for
implementation on October 1, 2013.
April 2013 Notice of Proposed Rulemaking to be published in the Federal
Register as mandated by Public Law 99-509. This notice will
include the final ICD-9-CM diagnosis and procedure codes for the
upcoming fiscal year. It will also include proposed revisions to the
DRG system on which the public may comment. The proposed
ICD-10-PCS New and Deleted Codes for October 1, 2013
New Codes for 2014
0 Medical and Surgical
4 Upper Arteries
V Restriction: Partially closing an orifice or the lumen of a tubular body part
Body Part Approach Device Qualifier
0 Abdominal Aorta 0 Open
3 Percutaneous
4 Percutaneous
Endoscopic
D Intraluminal Device J Temporary
04V00DJ Restriction of Abdominal Aorta with Temporary Intraluminal Device, Open Approach
04V03DJ Restriction of Abdominal Aorta with Temporary Intraluminal Device, Percutaneous
Approach
04V04DJ Restriction of Abdominal Aorta with Temporary Intraluminal Device, Percutaneous
Endoscopic Approach
Deleted Codes for 2014
0 Medical and Surgical
2 Heart and Great Vessels
V Restriction: Partially closing an orifice or the lumen of a tubular body part
Body Part Approach Device Qualifier
W Thoracic Aorta 0 Open
3 Percutaneous
4 Percutaneous
Endoscopic
D Intraluminal Device J Temporary
02VW0DJ Restriction of Thoracic Aorta with Intraluminal Device, Temporary, Open Approach
02VW3DJ Restriction of Thoracic Aorta with Intraluminal Device, Temporary, Percutaneous
Approach
02VW4DJ Restriction of Thoracic Aorta with Intraluminal Device, Temporary, Percutaneous
Endoscopic Approach
Revised ICD-10-PCS Section Title for 2014
Received in public comment, a proposal to change the title of Section D, Radiation Oncology to
Radiation Therapy, in order to allow codes in this section to be used for radiation therapy
procedures regardless of the diagnosed condition for which they were performed. Such
information will be contained in the diagnosis code.
18
ICD-10-PCS Annual Update Addenda for Index and Definitions Files
In response to public comment, CMS is undertaking the development of a more detailed set of
addenda for the Index and Definitions files for future updates, to be posted in both PDF and text
file formats.
The files will be produced using an automated process and must meet federal accessibility
requirements for using assistive technologies to read documents. The PDF file is intended for
individual users who want to review the changes made. The text file format is a machine
readable file that uses a separate term to identify each element defined in the source content. It is
intended for organizations that use automated processes to analyze and update the ICD-10-PCS
content.
Examples of the proposed Index and Definitions files addenda formats are provided below.
CMS welcomes input from users and technical developers concerning the ICD-10-PCS addenda
file formats.
Index Addenda, PDF example (addenda entries beginning with D)
Blank line
No change
D Add
Distal humerus Add
use Humeral Shaft, Right Add
use Humeral Shaft, Left Add
Distal humerus, involving joint Add
use Joint, Elbow, Right Add
use Joint, Elbow, Left
Add
Driver stent (RX) (OTW) use Intraluminal Device Blank line
19
Index Addenda, Text example (addenda entries beginning with D)
Lttr D
Main Add Distal humerus
Add use Humeral Shaft, Right
Add use Humeral Shaft, Left
Main Add Distal humerus, involving joint
Add use Joint, Elbow, Right
Add use Joint, Elbow, Left
Main Add Driver stent (RX) (OTW) use Intraluminal Device
Definitions Addenda, PDF example (Device definitions addenda in E-I)
No change Extraluminal Device
Revise from
LAP-BAND® Adjustable Gastric Banding System
Revise to
LAP-BAND® adjustable gastric banding system
Delete Hearing Device, Bone Conduction in Head and Facial Bones
Bone anchored hearing device
Add Hearing Device in Head and Facial Bones Bone anchored hearing device
No change Infusion Device
Add
InDura, intrathecal catheter (1P) (spinal)
Add
Tunneled spinal (intrathecal) catheter
Definitions Addenda, Text example (Device definitions addenda in E-I)
Row
Term Extraluminal Device
Includes Revise from LAP-BAND® Adjustable Gastric Banding System
Includes Revise to LAP-BAND® adjustable gastric banding system
Row Delete
Term Delete Hearing Device, Bone Conduction in Head and Facial Bones
20
Includes Delete Bone anchored hearing device
Row Add
Term Add Hearing Device in Head and Facial Bones
Includes Add Bone anchored hearing device
Row
Term Infusion Device
Includes Add InDura, intrathecal catheter (1P) (spinal)
Includes Add Tunneled spinal (intrathecal) catheter
21
Infusion of 4-Factor Prothrombin Complex Concentrate (4F-PCC)
Issue: Should new ICD-9-CM and ICD-10 PCS codes be created to identify a potential new
blood clotting factor drug, 4F-PCC, that contains blood clotting Factors II,VII, IX and X, and
Proteins C and S?
New Technology Application?
CSL Behring has submitted a new technology application for Kcentra™ 4-Factor Prothrombin
Complex Concentrate (4F-PCC) for FY 2014.
FDA Approval:
A Biologics License application (BLA) for Kcentra™ is currently under review and anticipated
FDA approval is expected in April 2013. Upon FDA approval, it is anticipated that Kcentra™ 4-
Factor Prothrombin Complex Concentrate (4F-PCC) will be indicated for the urgent reversal of
vitamin k antagonist (e.g. warfarin) therapy in patients with acute major bleeding.
Background:
Warfarin is highly effective at preventing blood clots for indications such as atrial fibrillation,
deep vein thrombosis, and mechanical heart valves and is widely used. However, warfarin
significantly raises the risk of bleeding in treated patients due to the development of coagulation
factor deficiency. Plasma and vitamin K are the current standard treatments for patients on
warfarin experiencing an acute major bleed, but the limitations include 1) inability to rapidly
reverse warfarin in bleeding patients further complicating and possibly delaying necessary
interventions in these critical patients, 2) scant evidence of efficacy, 3) risk of pathogen
transmission, and 4) transfusion associated adverse reactions, including but not limited to
Transfusion Associated Circulatory Overload (TACO) and Transfusion Related Acute Lung
Injury (TRALI).
Upon FDA approval, Kcentra™ will be the first and only 4-factor prothrombin complex
concentrate that is FDA-approved for rapid warfarin reversal in patients experiencing an acute
major bleed. Kcentra™ has been specifically-engineered to provide all four essential vitamin K-
dependent, non-activated coagulation factors (Factor II, Factor VII, Factor IX, and Factor X) in
addition to antithrombotic proteins C and S. Kcentra™ is heat treated, virus filtered and
lypophilized plasma protein concentrate made from pooled human plasma administered by
intravenous infusion. The potency and dosing of Kcentra™ is based on Factor IX units.
According to the manufacturer, the product is 25 times more concentrated than the equivalent
plasma dose, meaning that Kcentra™ therapy requires 87% less volume than plasma. It is
anticipated that Kcentra™ will be utilized primarily for inpatient hospital use. In addition, some
patients will receive the product in hospital emergency departments and outpatient hospitals. 4-
Factor Prothrombin Complex Concentrate has been available in Europe and Asia for more than
15 years.
According to the manufacturer, Kcentra™ represents a substantial clinical improvement in the
treatment of patients with acute severe bleeding who require immediate reversal of their warfarin
therapy by 1) providing a rapid, beneficial resolution of the patient’s blood clotting factor
22
deficiency, 2) decreasing the risk of exposure to blood borne pathogens, and 3) reducing the rate
of transfusion-associated complications.
ICD-9-CM Procedure Coding Options:
Option 1. Continue to assign code 99.06, Transfusion of coagulation factors, for the
Infusion of 4-Factor Prothrombin Complex Concentrate (4F-PCC).
Option 2. Create a new code under subcategory 00.9, Other procedures and interventions,
to uniquely capture the Infusion of 4-Factor Prothrombin Complex Concentrate (4F-
PCC).
New code 00.96 Infusion of 4-Factor Prothrombin Complex Concentrate
Infusion of 4F-PCC
Excludes: transfusion of coagulation factors (99.06)
transfusion of Factor IX complex (99.06)
CMS Recommendation: Option 2. As described above.
Interim Coding: In the interim, continue to assign code 99.06, Transfusion of coagulation
factors for the infusion of 4-Factor Prothrombin Complex Concentrate (4F-PCC).
ICD-10-PCS Coding Options:
Option 1. Continue to assign one of the following ICD-10-PCS codes under section 3 -
Administration, body system 0 – Circulatory, operation 2 – Transfusion, for the Infusion of 4-
Factor Prothrombin Complex Concentrate (4F-PCC).
30230W1 Transfusion of Nonautologous Factor IX into Peripheral Vein, Open Approach
30233W1 Transfusion of Nonautologous Factor IX into Peripheral Vein, Percutaneous
Approach
30240W1 Transfusion of Nonautologous Factor IX into Central Vein, Open Approach
30243W1 Transfusion of Nonautologous Factor IX into Central Vein, Percutaneous
Approach
30250W1 Transfusion of Nonautologous Factor IX into Peripheral Artery, Open
Approach
30253W1 Transfusion of Nonautologous Factor IX into Peripheral Artery, Percutaneous
Approach
30260W1 Transfusion of Nonautologous Factor IX into Central Artery, Open Approach
30263W1 Transfusion of Nonautologous Factor IX into Central Artery, Percutaneous
Approach
23
Option 2. Create a new substance, B, 4-Factor Prothrombin Complex Concentrate, under section
3 - Administration, body system 0 – Circulatory, operation 2 – Transfusion, for the Infusion of 4-
Factor Prothrombin Complex Concentrate (4F-PCC).
3 Administration
0 Circulatory
2 Transfusion: Putting in blood or blood products
Body System/Region Approach Substance Qualifier
3 Peripheral Vein
4 Central Vein
0 Open
3 Percutaneous
B 4-Factor
Prothrombin Complex
Concentrate
1 Nonautologous
5 Peripheral artery
6 Central artery
0 Open
3 Percutaneous
B 4-Factor
Prothrombin Complex
Concentrate
1 Nonautologous
CMS Recommendation: Option 2. As described above.
Interim Coding: In the interim, continue to assign one of the following ICD-10-PCS codes
under section 3 - Administration, body system 0 – Circulatory, operation 2 – Transfusion, for the
infusion of 4-Factor Prothrombin Complex Concentrate (4F-PCC).
30230W1 Transfusion of Nonautologous Factor IX into Peripheral Vein, Open Approach
30233W1 Transfusion of Nonautologous Factor IX into Peripheral Vein, Percutaneous
Approach
30240W1 Transfusion of Nonautologous Factor IX into Central Vein, Open Approach
30243W1 Transfusion of Nonautologous Factor IX into Central Vein, Percutaneous
Approach
30250W1 Transfusion of Nonautologous Factor IX into Peripheral Artery, Open
Approach
30253W1 Transfusion of Nonautologous Factor IX into Peripheral Artery, Percutaneous
Approach
30260W1 Transfusion of Nonautologous Factor IX into Central Artery, Open Approach
30263W1 Transfusion of Nonautologous Factor IX into Central Artery, Percutaneous
Approach
24
Implantation of Transprostatic Struts
Issue: Currently there is not a unique ICD-9-CM or ICD-10-PCS procedure code to describe the
implantation of transprostatic struts. This therapy was developed to treat symptoms due to
urinary outflow obstruction, secondary to benign prostatic hyperplasia (BPH).
New Technology Application? No, not at this time. The requester is considering submitting an
application for FY 2015.
FDA Approval: NeoTract, Inc. indicates that indication specific FDA de nova 510(k) clearance
for the Urolift® Permanent Adjustable Transprostatic Strut Implants and Delivery Device is
pending.
Background: Benign prostatic hyperplasia (BPH) is a naturally occurring and common
overgrowth of tissue in the prostate that can cause obstruction of the urethra as it courses through
the prostate. This obstruction can result in lower urinary tract symptoms (LUTS) such as
frequent urination, difficulty urinating, and nocturia (frequent need to urinate during the night).
LUTS can significantly impair work productivity, quality of life, and if left unaddressed, can
lead to chronic retention and kidney failure.
Transurethral resection of the prostate (TURP) has long been considered the gold standard for
BPH. However, TURP has a 20% perioperative morbidity rate and potential long-term
complications that require additional treatments and procedures, including
2% - 8% bleeding requiring transfusion;
3% permanent incontinence, often requiring artificial sphincter implant;
7% strictures, typically requiring urethral dilatation procedures;
10% erectile dysfunction, typically requiring medication or penile implant.1
In addition to the standard TURP, tissue can be removed via various laser technologies. While
these procedures have been shown to reduce bleeding, other complication rates remain similar to
TURP.
Technology and Procedure: The adjustable transprostatic UroLift
® struts are designed as
permanent implants intended to reduce symptoms due to urinary outflow obstruction, secondary
to BPH. An endoscopically guided delivery device is placed in the prostatic urethra and the
surgeon compresses the encroaching prostate lobe, thereby opening the prostatic urethra. The
transprostatic strut is then permanently implanted to hold the urethra in its new, less obstructed
shape. The implanted strut resists tension loading, thereby holding the urethra open. According
to the manufacturer, an important feature of the transprostatic strut is that it is adjustable in situ.
Because prostate wall thickness varies from patient to patient and even at different locations in a
single prostate, each implanted strut is sized to a unique shape to address the particular location
of implantation. Over time the prostate tissue remodels to a durable less obstructed
1 See Roehrborn, et. al. AUA Guideline on the Management of BPH: Diagnosis and Treatment Recommendations.
American Urological Association Education and Research, Inc. 2003.
25
configuration. Opening the urethra and reducing prostatic obstruction has been shown to
mitigate LUTS due to BPH.
The following steps are involved in the implant procedure:
Anesthesia – transprostatic strut implantation may be performed under general, spinal or
local anesthesia with oral or intravenous sedation.
Cystoscopy is conducted to assess urethral condition, rule out obstructive median lobe,
assess the condition of the bladder, and plan the placement for the various implantable
struts as needed (typically 4 transprostatic struts are implanted).
The cystoscopy sheath is then advanced into the bladder and the telescope bridge is
replaced with the UroLift® strut delivery device.
Under endoscopic guidance the physician determines precise location to compress the
obstructing prostatic lobe and implant each UroLift® transprostatic strut. The exact
number of implants is determined by the physician and can vary depending on size and
shape of the prostatic obstruction.
Conducting a final cystoscopy, the physician assesses the result with the goal of creating
a continuously open channel through the anterior aspect of the prostatic urethra.
Patient Population: The adjustable transprostatic UroLift® struts are designed as permanent
implants intended to reduce symptoms due to urinary outflow obstruction, secondary to BPH for
men over the age of 50. The device is specifically indicated for prostates less than or equal to 80
cc and with no obstructive median lobe.
BPH is a significant health care burden, and is the fourth most common diagnosis for men over
age 50. BPH is a progressive disease and drugs are palliative in nature but do not effectively
treat the underlying condition. The gold standard surgery for patients diagnosed with BPH,
TURP, is typically performed as an inpatient procedure with a multi-night hospital stay and the
related complications can be considerable. BPH impacts 70 percent of men in their 60’s and 90
percent of men in their 80’s. In the US, 15 million men suffer from symptoms severe enough to
discuss treatment.2 The majority of men are adequately treated with BPH medication and
approximately 150,000 are surgically treated each year. The requester anticipates that a subset of
this population will require transprostatic strut implantation once introduced to the US market
due to its reduced morbidity, rapid onset of symptom relief.
Outcomes: Clinical studies conducted outside the US3,4
have demonstrated that the implantation
of transprostatic struts is a straightforward procedure that produces immediate, visible results and
significantly lower morbidity.
Clinically Effective – Study results demonstrate that mechanically opening the prostatic
urethra by retracting encroaching prostate lobes relieves obstruction and successfully
2 US Census Bureau International Database. 3 McNicholas, TA, Woo HH, et al Minimally Invasive Prostatic Urethral Lift: Surgical Technique and
Multinational Experience”, Eur Urol, Jan 2013, pp 1-8 4 Chin PT, Bolton DM, et al: Prostatic Urethral Lift: Two Year Results After Treatment for Lower Urinary Tract
Symptoms Secondary to Benign Prostatic Hyperplasia. Urology, 2012. Pgs 5-11
26
treats lower urinary tract symptoms stemming from BPH. Symptom mitigation far
exceeds that of medical therapy and durability has been shown to three years.
Safe – Results indicate that implantation is safe and effective at treating lower urinary
tract symptoms due to BPH with few complications as compared to other treatments.
There has been no incidence of transfusion, permanent incontinence, or sexual
dysfunction, all common with the gold standard BPH surgery.
ICD-9-CM Procedure Coding options:
Coding option 1. Do not create a new code. Due to the restrictions of the Partial Code Freeze,
CMS is unable to propose a new ICD-9-CM procedure code at this time to uniquely describe the
implantation of transprostatic struts as the requester did not submit an application for New
Technology. Should the requester decide to submit an application for FY 2015 we can
reconsider a new code request.
Interim Coding: CMS recommends procedure code 58.6, Dilation of urethra, to identify the
implantation of transprostatic struts used to open the prostatic urethra.
ICD-10-PCS Coding Options:
Option 1. Code the implantation of transprostatic struts to open the prostatic urethra to the root
operation Supplement.
0 Medical and Surgical
T Urinary System
U Supplement: Putting in or on biological or synthetic material that physically reinforces and/or
augments the function of a portion of a body part
Body Part Approach Device Qualifier
D Urethra 0 Open
4 Percutaneous
Endoscopic
7 Via Natural or
Artificial Opening
8 Via Natural or
Artificial Opening
Endoscopic
X External
7 Autologous Tissue
Substitute
J Synthetic Substitute
K Nonautologous
Tissue Substitute
Z No Qualifier
0TUD8JZ Supplement Urethra with Synthetic Substitute, Via Natural or Artificial Opening
Endoscopic
0TUDXJZ Supplement Urethra with Synthetic Substitute, External Approach
Rationale: Currently, in ICD-10-PCS, the female equivalent “lift” procedures for incontinence
are coded in this manner. In this procedure for males, the device is being used to keep the urethra
open and functioning correctly, instead of having the prostate push on it.
The body part key currently instructs to use the body part “Urethra” for prostatic urethra.
Prostatic urethra Use: Urethra
27
Option 2. Code the procedure with root operation Dilation.
0 Medical and Surgical
T Urinary System
7 Dilation: Expanding an orifice or the lumen of a tubular body
Body Part Approach Device Qualifier
3 Kidney Pelvis, Right
4 Kidney Pelvis, Left
6 Ureter, Right
7 Ureter, Left
8 Ureters, Bilateral
B Bladder
C Bladder Neck
D Urethra
0 Open
3 Percutaneous
4 Percutaneous Endoscopic
7 Via Natural or Artificial
Opening
8 Via Natural or Artificial
Opening Endoscopic
D Intraluminal
Device
Z No Device
Z No Qualifier
Option 3. Code the procedure with root operation Insertion, body part Prostate and consider
new device value?
0 Medical and Surgical
V Male Reproductive System
H Insertion: Putting in a nonbiological appliance that monitors, assists, performs, or prevents a
physiological function but does not physically take the place of a body part
Body Part Approach Device Qualifier
0 Prostate 0 Open
3 Percutaneous
4 Percutaneous Endoscopic
7 Via Natural or Artificial
Opening
8 Via Natural or Artificial
Opening Endoscopic
1 Radioactive
Element
M ?
Z No Qualifier
Option 4. Add the body part value Prostate to root operation Supplement in the ICD-10-PCS
tables, with applicable approach values (3 codes)
0 Medical and Surgical
V Male Reproductive System
U Supplement: Putting in or on biological or synthetic material that physically reinforces and/or
augments the function of a portion of a body part
Body Part Approach Device Qualifier
0 Prostate 0 Open
7 Via Natural or
Artificial Opening
8 Via Natural or
Artificial Opening
Endoscopic
J Synthetic Substitute Z No Qualifier
28
Implantation of Epiretinal Prosthesis
Issue: Currently, there are not ICD‐9‐CM procedure codes which clearly capture the procedures
involving the implant of an epiretinal visual prosthesis to restore vision.
New Technology Application? Yes.
This procedure is currently being considered for a New Technology Add‐on Payment for FY
2014.
Food and Drug Administration (FDA) approval?
The Argus ® II Retinal Prosthesis System received an HDE approval by the FDA in February
2013.
Background: The Argus ® II System is an active implantable medical device that partially
restores vision for patients that are profoundly blind due to retinitis pigmentosa. The system
employs electrical signals to bypass dead photo-receptor cells and stimulate the overlying
neurons according to a real-time video signal that is wirelessly transmitted from an externally
worn video camera.
The Argus ® II System consists of an epiretinal implant that is fully implanted in and around the
eye, a video camera mounted on a pair of glasses, and a control unit that is worn or carried by
the patient. The system provides electrical stimulation of the retina to induce visual perception in
blind patients (analogous to a cochlear implant for the restoration of hearing). It is indicated for
use in patients with severe to profound retinitis pigmentosa with bare or no light perception in
both eyes.
The Argus ® II System provides visual information that can range, depending on the patient,
from light detection to form detection. Patients are able to use this visual information to perform
functional tasks (e.g., locating windows and doors, following lines in a cross walk, sort laundry,
read letters), allowing them to feel more connected with others (e.g., seeing when a person
approaches them or when someone walks away). For people with bare or no light perception,
even limited restoration of vision can make a significant difference in their lives.
In the Argus ® II System, the video camera on the patient‐worn glasses captures a video image.
The camera signal is sent to the Video Processing Unit (VPU) which processes the camera
image and transforms it into electrical signals. The electrical signals are then sent to a transmitter
coil mounted on the glasses. The transmitter coil sends both data and power via radio‐ frequency
(RF) telemetry to the implanted epiretinal visual prosthesis. The implant receives the radio‐
frequency commands and delivers stimulation to the retina via an array of electrodes that is
secured to the retina with a retinal tack.
29
In patients with retinitis pigmentosa, the photoreceptor cells in the retina, which normally
transduce incoming light into an electro‐chemical signal, have lost most of their function. The
stimulation pulses delivered to the retina via the electrode array of the Argus ® II Retinal
Prosthesis are intended to mimic the function of these degenerated photoreceptor cells. These
pulses induce cellular responses in the remaining, viable retinal nerve cells that travel through the
optic nerve to the visual cortex, where they are perceived as phosphenes (spots of light). Patients
learn to interpret the visual patterns produced by these phosphenes to use them for functional
actions.
The epiretinal visual prosthesis implant is responsible for receiving information from the external
components of the system and electrically stimulating the retina to induce visual perception.
The retinal implant consists of: (a) a receiving coil for receiving information and power from the
external components of the Argus ® II System; (b) electronics to drive stimulation of the
electrodes; and (c) an electrode array. The receiving coil and electronics are secured to the
outside of the eye using a standard scleral band and sutures, while the electrode array is secured
to the surface of the retina inside the eye by a retinal tack. A cable, which passes through the eye
wall, connects the electronics to the electrode array. A pericardial graft is placed over the
extra‐ocular portion on the outside of the eye.
The implant receives power and data commands wirelessly from an external unit. The external
components include the Argus ® II Glasses and the Argus II Video Processing Unit (VPU). A
small, light‐weight video camera and transmitting coil are mounted on the glasses. The telemetry
coils and radio‐frequency system are mounted on the temple arm of the glasses for transmitting
data from the VPU to the implant.
The glasses are connected to the VPU by a cable. The VPU is worn by the patient, typically, on a
belt or a strap. The VPU is used to process the images from the video camera and convert the
images into electrical stimulation commands which are transmitted wirelessly to the implant.
The surgical implant procedure is performed under general anesthesia. The implant procedure
takes approximately four hours and consists primarily of lens removal (if present), scleral
buckling, three port pars plana vitrectomy, epiretinal membrane peeling, and pericardial grafting.
As the results of the studies indicate, the Argus II System provides subjects with clinical benefit
as measured by objectively‐scored functional vision tests. Subjects performed better with the
Argus ® II System ON vs. OFF on orientation and mobility tests (finding a door and following a
line on the ground or street) and on functional vision tasks (sorting white, black and grey socks;
following an outdoor sidewalk; and determining the direction of a person walking by).
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ICD-9-CM Procedure Coding Options:
Option 1: Do not create any new procedure codes for the implant of epiretinal visual prosthesis.
There is currently no ICD-9-CM code for the implant of epiretinal visual prosthesis. Codes
14.73(Mechanical vitrectomy by anterior approach) and 14.74 (Other mechanical vitrectomy) are
reported for the vitrectomy. The vitrectomy codes can continue to be used as a proxy for the
implant of the epiretinal visual prosthesis. Any other associated procedures could also be
reported.
Option 2: Create new ICD‐9‐CM procedure codes for Implantation of epiretinal visual
prosthesis.
Create new subcategory 14.8 Implantation of epiretinal visual prosthesis
New code 14.81 Implantation of epiretinal visual prosthesis
Includes lens removal if present, scleral buckling,
vitrectomy, epiretinal membrane peeling and
pericardial grafting
New code 14.82 Removal of epiretinal visual prosthesis
Includes 360‐degree limbal peritomy and vitrectomy if
performed, and device extraction
New code 14.83 Revision of epiretinal visual prosthesis
Includes tack replacement, device relocation, and/or
replacement of pericardial grafting, if needed
CMS Recommendation: Option 2. Create new codes to capture the implantation of an
epiretinal visual prosthesis.
Interim Coding: In the interim, continue reporting codes 14.73 (Mechanical vitrectomy by
anterior approach) and 14.74 (Other mechanical vitrectomy) for the vitrectomy as well as any
other associated procedures.
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Proposed ICD-10-PCS Code:
New ICD-10-PCS device value Epiretinal Visual Prosthesis in table 08H Insertion of Eye for the
retina body part values.
Section 0 Medical and Surgical
Body System 8 Eye
Operation H Insertion: Putting in a nonbiological appliance that monitors,
assists, performs, or prevents a physiological function but does not physically take the place of a